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Trial record 1 of 1 for:    babyee pilot
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Measurement of Energy Metabolism in Infants (BabyEE)

This study is currently recruiting participants.
Verified August 2017 by Leanne Redman, Pennington Biomedical Research Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02683473
First Posted: February 17, 2016
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center
  Purpose
The purpose of this study is to measure energy expenditure during the first 3 months of life in infants.

Condition
Infant Development Infant Overnutrition

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Measurement of Energy Metabolism in Infants: BabyEE Pilot

Further study details as provided by Leanne Redman, Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Energy Expenditure [ Time Frame: Between 1 and 3 months of age ]
    Infant metabolic chamber and doubly labeled water


Secondary Outcome Measures:
  • Infant sucking behavior [ Time Frame: Between 1 and 3 months of age ]
    Neonur device used on an infant bottle


Estimated Enrollment: 40
Study Start Date: February 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Infants
Infants aged 1-3 months

Detailed Description:

This study intends to establish the feasibility of undertaking comprehensive metabolic phenotyping in infants. The overarching aim is to complete a prospective assessment of energy expenditure in the new infant metabolic chamber approximately one week apart to determine the accuracy and precision of infant protocols related to energy metabolism (sleeping metabolic rate, resting metabolic rate, diet-induced thermogenesis), physical activity, and sucking behavior. This cross-sectional study will answer the following questions:

  1. What is the test re-test reliability of measuring energy expenditure (sleeping metabolic rate, resting metabolic rate, diet-induced thermogenesis) in an infant under the same conditions, 5-7 days apart?
  2. What is the reliability of 24h energy expenditure estimated by the infant metabolic chamber in comparison to a 7-day doubly labeled water study?
  3. How do energy expenditure measurements in infants need to be adjusted to account for variability in infant size and body composition?
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Month to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Full-term infants aged 1 to 3 months who are exclusively fed breast milk and/or infant formula will be recruited
Criteria

Inclusion Criteria:

  • Healthy, full-term infant
  • Aged 1 month (28 days) to 3 months (12 weeks, 6 days)
  • Exclusively fed breast milk and/or infant formula
  • Willing to accept doubly-labeled water
  • If breastfed, willing to feed from a feeding bottle device similar to an infant feeding bottle
  • If breastfed, willing to accept pumped breast milk for some of the study procedures

Exclusion Criteria:

  • Unable to complete 2 clinic visits 5-7 days apart at Pennington Biomedical Research Center
  • Unable or unwilling to eat from an infant feeding bottle
  • Born preterm (< 37 weeks gestation)
  • Congenital abnormality or disability
  • Exposure to gestational diabetes
  • Gastric reflux
  • Acute illness within 7 days of the study (fever, diarrhea)
  • Use of medications to treat a chronic condition (does not include use of vitamin supplements or PRN medication for flatulence)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683473


Contacts
Contact: Abby Altazan, M.S. (225) 763-2801 abby.altazan@pbrc.edu

Locations
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Abby Duhé, M.S.    225-763-2801    abby.duhe@pbrc.edu   
Principal Investigator: Leanne M Redman, Ph.D.         
Sub-Investigator: Eric Ravussin, Ph.D.         
Sub-Investigator: Abby Duhé Altazan, M.S.         
Sub-Investigator: Daniel Hsia, M.D.         
Sponsors and Collaborators
Pennington Biomedical Research Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Leanne M Redman, Ph.D. Pennington Biomedical Research Center
  More Information

Responsible Party: Leanne Redman, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02683473     History of Changes
Other Study ID Numbers: PBRC 2015-061
P30DK072476-10 ( U.S. NIH Grant/Contract )
First Submitted: January 14, 2016
First Posted: February 17, 2016
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Overnutrition
Infant Nutrition Disorders
Nutrition Disorders